Parkinson Disease, IdiopathicNCT06639945
Clinical Trail of Transcranial MR-guided Focused Ultrasound in the Treatment of Motor Symptoms in Patients With Parkinson' Disease
A study testing transcranial MR-guided focused ultrasound in people with Parkinson Disease, Idiopathic, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Randomized, double-blind, self-cross-over control (After the first visit, patients are divided into two groups, randomly receiving real stimulation/placebo stimulation. 14 days later, during the second visit, a cross-over occurs: patients who received real stimulation in the first visit will receive placebo… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Parkinson Disease, Idiopathic
- What is being tested?
- transcranial MR-guided focused ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2025to 5 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the clinical probable Parkinson's disease diagnostic criteria proposed by MDS-UPDRS;
- a stable dosage of L-DOPA medications for at least one month;
- no contraindications for MRI.
Who cannot join
- History of stroke or seizures, dementia; previous surgical interventions for Parkinson's disease; contraindications for TMS (such as cardiac pacemakers, transcranial implants, and metal implants); severe mental disorders such as depression or psychosis; inability to understand the study procedures; use of antipsychotic medications; pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200092
About this study
Randomized, double-blind, self-cross-over control (After the first visit, patients are divided into two groups, randomly receiving real stimulation/placebo stimulation. 14 days later, during the second visit, a cross-over occurs: patients who received real stimulation in the first visit will receive placebo stimulation in the second visit, and vice versa. The grouping situation remains blinded for the patients, EEG analysis, and video analysis.)
- Conditions
- Parkinson Disease, Idiopathic
- Being tested
- transcranial MR-guided focused ultrasound
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial MR-guided focused ultrasoundDevice
MRI-guided transcranial focused ultrasound (MRgFUS) combines magnetic resonance imaging (MRI) with focused ultrasound to target specific areas in the brain non-invasively. MRgFUS allows for treatment without surgical incisions, leading to fewer risks and a quicker recovery. MRI provides real-time imaging that helps precisely locate and treat affected brain regions, such as the thalamus or globus pallidus.The procedure allows for continuous monitoring of the treatment effects, enabling adjustments as needed.
| Study group | Role | What they receive |
|---|---|---|
| Verum stimulation followed by Sham stimulation | Experimental | Not described Receives: Device: transcranial MR-guided focused ultrasound |
| Sham stimulation followed by Verum stimulation | Experimental | Not described Receives: Device: transcranial MR-guided focused ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
UPDRS-III
Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score of part III. The part III of the MDS-UPDRS assess motor function in best on phase. The score range is 0-132, where a higher score means more severe motor impairment.
Measured: Beginning and end of each experimental session
Secondary outcomes (1)
cortical activation detected by scalp EEG
Resting-state scalp EEG was recorded before, throughout, and following sonication.
Measured: From baseline (pre-sonication) to 10 minutes post-sonication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start7 Jan 2025
- Primary completion5 Nov 2025
- Study completion5 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease, IdiopathicStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengguo Liu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639945
- Sponsor's protocol ID
- XHEC-C-2024-125-2-1
- Status last verified
- May 2026
- First submitted
- 11 Oct 2024
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trail of Transcranial MR-guided Focused Ultrasound in the Treatment of Motor Symptoms in Patients With Parkinson' Disease
- ClinicalTrials.gov ID
- NCT06639945
- Acronym / sponsor ID
- XHEC-C-2024-125-2-1
- Conditions
- Parkinson Disease, Idiopathic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double-blind, self-cross-over control (After the first visit, patients are divided into two groups, randomly receiving real stimulation/placebo stimulation. 14 days later, during the second visit, a cross-over occurs: patients who received real stimulation in the first visit will receive placebo stimulation in the second visit, and vice versa. The grouping situation remains blinded for the patients, EEG analysis, and video analysis.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum stimulation followed by Sham stimulation | Experimental | Device: transcranial MR-guided focused ultrasound |
| Sham stimulation followed by Verum stimulation | Experimental | Device: transcranial MR-guided focused ultrasound |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets the clinical probable Parkinson's disease diagnostic criteria proposed by MDS-UPDRS;
- a stable dosage of L-DOPA medications for at least one month;
- no contraindications for MRI.
Key exclusion criteria (1 listed)
- History of stroke or seizures, dementia; previous surgical interventions for Parkinson's disease; contraindications for TMS (such as cardiac pacemakers, transcranial implants, and metal implants); severe mental disorders such as depression or psychosis; inability to understand the study procedures; use of antipsychotic medications; pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial MR-guided focused ultrasoundMRI-guided transcranial focused ultrasound (MRgFUS) combines magnetic resonance imaging (MRI) with focused ultrasound to target specific areas in the brain non-invasively. MRgFUS allows for treatment without surgical incisions, leading to fewer risks and a quicker recovery. MRI provides real-time imaging that helps precisely locate and treat affected brain regions, such as the thalamus or globus pallidus.The procedure allows for continuous monitoring of the treatment effects, enabling adjustments as needed. | Device | Sham stimulation followed by Verum stimulation, Verum stimulation followed by Sham stimulation |
Primary outcome
UPDRS-III
Time frame: Beginning and end of each experimental session
Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score of part III. The part III of the MDS-UPDRS assess motor function in best on phase. The score range is 0-132, where a higher score means more severe motor impairment.
1 secondary outcome
cortical activation detected by scalp EEG
Time frame: From baseline (pre-sonication) to 10 minutes post-sonication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial MR-guided focused ultrasound in people with Parkinson Disease, Idiopathic, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UPDRS-III (time frame: Beginning and end of each experimental session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.